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Telephone-Based Support for Caregivers of Patients With Dementia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052104
First Posted: January 23, 2003
Last Update Posted: August 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Rhode Island Hospital
  Purpose
The purpose of this study is to develop an effective, low-cost, telephone-based intervention to reduce anxiety, depression, and feelings of burden and stress in caregivers of patients with dementia. This study will also determine whether the intervention can alter the course of dementia.

Condition Intervention Phase
Dementia Behavioral: Cognitive-Behavioral Family Systems Intervention Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Telephone Intervention for Dementia Caregivers

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Estimated Enrollment: 85
Study Start Date: December 2001
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:
Caregivers are randomized to receive either telephone-based intervention or standard medical care. Both groups receive a resource packet containing information about caring for someone with dementia and a list of local resources. Caregivers in the intervention group also receive a series of telephone calls over 12 months, during which education, emotional support, and training in problem-solving skills are provided by trained therapists. Caregivers in the standard care group receive no additional psychosocial intervention. Participants are assessed pre-treatment, mid-treatment (6 months), post-treatment, and at a 3-month follow-up.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient Inclusion Criteria:

  • DSM-IV diagnosis of dementia (vascular, mixed, or associated with Alzheimer's disease)
  • Lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers
  • 50 years old or older
  • Resides in Southeastern New England

Caregiver Inclusion Criteria:

  • Living with a person with dementia
  • Provides care for at least 6 months for at least 4 hours a day
  • English as primary language
  • Telephone access
  • Resides in Southeastern New England

Patient Exclusion Criteria:

  • Major acute medical condition affecting independent functioning

Caregiver Exclusion Criteria:

  • Acute medical illness
  • Cognitive impairment as defined by an MMSE score < 25
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052104


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
National Institute of Mental Health (NIMH)
  More Information

ClinicalTrials.gov Identifier: NCT00052104     History of Changes
Other Study ID Numbers: R21MH062561 ( U.S. NIH Grant/Contract )
DSIR GT-GS
First Submitted: January 22, 2003
First Posted: January 23, 2003
Last Update Posted: August 9, 2013
Last Verified: March 2008

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders